Back to resultsClinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CITUS Dry Syrup
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Children aged over 24 months and under 15 years.
- Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.
- NIS mean total score of 1-week in baseline should be over 4.0.
Exclusion Criteria:
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).
- Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.
- Patient who has rhinitis not caused by allergy.
- Acute or chronic sinusitis.
- Patient who has medical history of allergy in seasonal pollen during the trial.
- Patient who has had eyes or nose surgery within 3 months prior to the trial.
- Patient who has had eye or upper airway infection within 1 week prior to the treatment period.
- Beginning immunotherapy or dose of change within 1 month prior to the trial.
- Patient who has clinical history of sensitivity to allergic rhinitis medication.
- Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.
- Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.
- Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.
- For girl who had her first period, result of pregnancy test was positive.
Sites / Locations
- Seoul National University Hodpital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CITUS Dry Syrup
Placebo
Arm Description
Pranlukast dry syrup 10%
Placebo
Outcomes
Primary Outcome Measures
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit).
NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale [Score 0(best) to 3(worst)].
Secondary Outcome Measures
Assessing improvement of symptom by physician
Assessing improvement of symptom by patient
Mean change of Individual NIS
Ratio distribution of NIS at end of week 4
Percentage of each NIS score.
Cure rate
Cure rate for each symptom
Use of rescue medication
Change of Instantaneous NIS
Full Information
NCT ID
NCT01539304
First Posted
February 6, 2012
Last Updated
February 26, 2012
Sponsor
SamA Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01539304
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
Official Title
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SamA Pharmaceutical Co., Ltd
4. Oversight
5. Study Description
Brief Summary
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CITUS Dry Syrup
Arm Type
Experimental
Arm Description
Pranlukast dry syrup 10%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CITUS Dry Syrup
Intervention Description
Pranlukast 10% dry syrup, b.i.d.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo dry syrup, b.i.d
Primary Outcome Measure Information:
Title
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
Description
Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit).
NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale [Score 0(best) to 3(worst)].
Time Frame
4 week treatment period (from baseline through the end of week 4)
Secondary Outcome Measure Information:
Title
Assessing improvement of symptom by physician
Time Frame
from baseline through the end of week 4
Title
Assessing improvement of symptom by patient
Time Frame
from baseline through the end of week 4
Title
Mean change of Individual NIS
Time Frame
from baseline through the end of week 4
Title
Ratio distribution of NIS at end of week 4
Description
Percentage of each NIS score.
Time Frame
from baseline through the end of week 4
Title
Cure rate
Time Frame
from baseline through the end of week 4
Title
Cure rate for each symptom
Time Frame
from baseline through the end of week 4
Title
Use of rescue medication
Time Frame
from baseline through the end of week 4
Title
Change of Instantaneous NIS
Time Frame
from baseline through the end of week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged over 24 months and under 15 years.
Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.
NIS mean total score of 1-week in baseline should be over 4.0.
Exclusion Criteria:
Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).
Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.
Patient who has rhinitis not caused by allergy.
Acute or chronic sinusitis.
Patient who has medical history of allergy in seasonal pollen during the trial.
Patient who has had eyes or nose surgery within 3 months prior to the trial.
Patient who has had eye or upper airway infection within 1 week prior to the treatment period.
Beginning immunotherapy or dose of change within 1 month prior to the trial.
Patient who has clinical history of sensitivity to allergic rhinitis medication.
Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.
Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.
Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.
For girl who had her first period, result of pregnancy test was positive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Yull Koh, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bok Yang Pyun, MD
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Won Oh, MD
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeong Ho Na, MD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo Jong Hong, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyun Hee Kim, MD
Organizational Affiliation
The Catholic University of Korea Bucheon St.Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dae Hyun Lim, MD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kang Mo Ahn, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myung Hyun Sohn, MD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Tack Kim, MD
Organizational Affiliation
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hodpital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
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